Mednorth Urgent Care

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a record review and an interview with technical consultant (TC) #1, the laboratory failed to establish and perform competency assessment for the technical supervisor listed on the CMS-209 Laboratory Personnel Report from August 6, 2023 to August 6, 2025. Findings: 1. A review of the CMS-209 Form revealed one of one personnel listed as the technical consultant. No competency assessment based on the technical consultant position was available for review from August 6, 2023, to August 6, 2025. 2. A record review of the laboratory's procedure manual revealed the laboratory failed to have a policy or procedure to assess the technical consultant position. 3. An interview on August 6, 2025, at 11:30 AM with TC #1 confirmed the laboratory failed to perform competency assessment for the position of technical consultant listed on the CMS-209 form from August 6, 2023 to August 6, 2025. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on observation, procedures, and an interview with technical consultant (TC) #1, the laboratory failed to follow their written procedures to label two of two patient urine specimens with either the patient's full name and date of birth, or at least two patient identifiers on August 6, 2025. Findings: 1. Observed on August 6, 2025, at 12: 00 PM, two patient specimen cups containing urine in the sink with just initials, the specimen cups lacked either a patient label or two patient identifiers. 2. A review of the "Specimen Collection Procedure and Policies" revealed laboratory staff failed to label the urine specimen cups with either the patient's full name and date of birth or at least two patient identifiers. 3. An interview with TC #2 on August 6, 2025, at 12:05 PM confirmed the laboratory staff failed to label two of two patient urine specimens with either the patient's full name and date of birth, or at least two patient identifiers on August 6, 2025. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on a record review, product inserts, and an interview with the technical consultant (TC #1), the laboratory failed to verify the acceptability of each new lot of immunoassay quality control (QC) for two of two analytes performed on the FREND Immunoassay System from August 6, 2023, to August 6, 2025. Findings: 1. The laboratory failed to follow the manufacturer's instructions to "establish its own mean and standard deviation" of each new lot of CLINIQA Liquid QC immunoassay control performed on the FREND Immunoassay System. 2. QC records lacked verifications studies for new immunoassay control lots for Prostate Specific Antigen (PSA) and Thyroid Stimulating Hormone (TSH) analytes performed on the FREND Immunoassay System. 3. A review of the annual test volume report revealed that 34 PSA and 9 TSH patient tests were performed in the last 12 months. 4. An interview with TC #1 on August 6, 2025, at 1:23 PM confirmed the laboratory failed to verify the acceptability of each new lot of immunoassay QC for analytes PSA and TSH performed on the FREND Immunoassay System from August 6, 2023, to August 6, 2025 D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a record review, Laboratory Personnel Report CMS-209 Form, and an interview with the technical consultant (TC #1), the technical consultant failed to perform their responsibility to evaluate the competency of three of three testing personnel (TP) for eight moderate complexity tests performed in the laboratory from August 6, 2023, to August 6, 2025. Findings: 1. A review of the CMS-209 form dated August 2, 2025, listed one technical consultant (TC #1) and three testing personnel (TP #1, #2, #3). 2. TC #1 failed to perform the competency assessments for each moderate test semi-annually during the first year that laboratory personnel test patient specimens and annually thereafter for the years 2024 and 2025. a. A review of the "Competency Assessment" worksheets lacked the six procedures for each moderate test: complete blood counts (CBC), troponin, creatinine, myoglobin, D-Dimer, brain natriuretic peptide (BNP), Prostate Specific Antigen (PSA) and Thyroid Stimulating Hormone (TSH). b. A review of the "New Employee Checklist" and "Competency Assessment" worksheets revealed that TP #1 performed the assessment for TP #2 on May 22, 2025, and May 23, 2025, and for TP #3 on June 6, 2025, and June 26, 2025. TP #1 had not been qualified as the technical consultant. c. TP #1 failed to have a competency assessment performed for the years 2024 and 2025. 3. An interview with TC #1 on August 6, 2025, at 11:30 AM revealed that TC #1 was not aware of the need to perform competency assessments for each moderate complexity test and confirmed the findings listed above from August 6, 2023, to August 6, 2025. -- 3 of 3 --

Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of hematology, chemistry, urinalysis and endocrinology procedures, the laboratory failed establish and follow written policies and procedures that ensure positive identification of a patient's specimen (see D5203) and failed establish and follow written procedures to assess testing personnel and technical consultant competency (see D5209). D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on observation, review of procedures, and interview with the Technical Consultant (TC) #1, the laboratory failed to establish and follow written procedures to ensure positive identification of a patient's urine specimens throughout the testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- process. Findings: 1. Observed two urine specimens in laboratory sink labeled with last name on lid. 2. Review of Specimen Collection Procedures and Policies state "All specimens sent to the laboratory for on-site testing or send out tests must be labeled with the following information: Patient's full name; Patients ID number; Date of birth; Time and Date of collection; Initials of person collecting the specimen." 3. Interview with the TC#1 on December 1, 2021 at 11:25 AM, confirmed the laboratory failed to follow written procedures to ensure positive identification of patient's urine specimens from the time of collection through completion of testing. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a record review, procedures, and an interview with the technical consultant (TC) #1, the laboratory failed to follow procedures and perform competency assessment for the testing personnel and technical consultant listed on the CLIA CMS- 209 Personnel Report form. Findings: 1. A record review of the CMS-209 Personnel Report Form revealed four out of four testing personnel listed failed to have competency assessment performed in 2020. 2. No competency assessment documents were available for the technical consultant from January 1, 2019 to December 1, 2021. 3. A review of the laboratory's Quality Assurance Program procedure states, "All personnel are evaluated semi-annually in the first year of employment and annually thereafter." 4. A review of the laboratory's Quality Assurance Program procedure revealed, "As laboratory director some of the responsibilities that may be delegated to the technical consultant include: Training of personnel, assessing competency of the personnel and annual reviews." 5. An interview on December 1, 2021 at 10:00 AM, confirmed the laboratory failed to follow procedure and perform competency for the positions of technical consultant and testing personnel listed on the CMS-209 Personnel Report form. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of hematology, chemistry and endocrinology procedures, the laboratory failed to include reference intervals (normal values) in their hematology procedure (see D5403), failed to ensure immunoassay quality control materials were not used past their expiration date (see D5417), and failed to define, and perform a -- 2 of 5 -- function check protocol to verify the accuracy of pipettes and centrifuge (see D5435) and failed to identify and correct problems to prevent recurrence and failed to document and monitor